Impulse Dynamics OPTIMIZER Smart Mini Manual de usuario
Part No.: 13-250-004-EU Rev. 02
OPTIMIZER™ Smart Mini
System
* * *
For the Treatment of
Moderate to Severe Heart Failure
Patient’s Manual
Impulse Dynamics (USA) Inc.
Suite 100
50 Lake Center Executive Parkway
401 Route 73 N Bldg. 50
Marlton, NJ 08053-3425
Impulse Dynamics Germany GmbH
MAC Main Airport Center
Unterschweinstiege 2-14
60549 Frankfurt am Main
Germany
OPTIMIZER™ and CCM™ are trademarks of Impulse Dynamics.
OPTIMIZER® is a US registered trademark property of Impulse Dynamics
The information in this document can be changed without prior notice.
No part of this manual may be reproduced or transmitted in any way or by
any means, either electronic or mechanical, for any purpose without the
prior express written consent of Impulse Dynamics.
The OPTIMIZER Smart Mini system and the CCM technology are
protected by several U.S. Patents. For an up-to-date list of relevant
patents and patent applications, visit our patents page:
http://www.impulse-dynamics.com/us/patents
Revision 02, Date of Issue: 2021-09-28
i
TABLE OF CONTENTS
IMPORTANT MEDICAL NOTICE ........................................................................... i
1.0 INTRODUCTION .......................................................................................... 1
2.0 THE OPTIMIZER SMART MINI SYSTEM .................................................... 1
2.1 OPTIMIZER Smart Mini Implantable Pulse Generator ....................... 2
2.2 Vesta Charger .................................................................................... 3
3.0 POTENTIAL COMPLICATIONS .................................................................. 4
3.1 Complications Associated with Implantation ...................................... 4
3.2 Complications Associated with Device / Charger Operation .............. 5
4.0 FOLLOWING IMPLANTATION ................................................................... 6
5.0 LIVING WITH YOUR OPTIMIZER SMART MINI IPG .................................. 7
5.1 General Expectations ......................................................................... 7
5.2 Effect on Your Activities ..................................................................... 7
5.3 Medications ........................................................................................ 7
5.4 How Other Devices May Affect Your OPTIMIZER Smart Mini IPG .... 7
5.5 The Importance of Your Implanted Medical Device Identification Card
........................................................................................................... 9
6.0 VESTA CHARGER .................................................................................... 10
6.1 System Components ........................................................................ 10
6.2 Features ........................................................................................... 11
6.3 Description ....................................................................................... 12
6.4 Charging Method .............................................................................. 12
6.5 Removal and Installation of the Plug Adapter .................................. 13
6.5.1 Removal of the Plug Adapter ................................................. 13
6.5.2 Installation of the Plug Adapter .............................................. 14
6.6 Charging Your Vesta Charger .......................................................... 15
6.7 Charging Your OPTIMIZER Smart Mini IPG .................................... 18
6.8 Termination of the Charging Session ............................................... 22
6.8.1 Early Termination of Charging Session .................................. 22
6.8.2 Termination of Charging Session Due to IPG Temperature ... 23
ii
6.8.3 Termination of Charging Session Due to Charging IPG Timeout
24
6.8.4 Termination of Charging Session Due to Low Charger Battery
Level ....................................................................................... 24
6.9 Vesta Charger Placement When Not Being Used for Device Charging
......................................................................................................... 25
6.10 Frequency of Charging Sessions ..................................................... 25
6.11 Communications with Your OPTIMIZER Smart Mini IPG ................. 26
6.12 Call Doctor Alert Codes .................................................................... 28
6.13 Cleaning ........................................................................................... 30
6.14 Maintenance ..................................................................................... 30
6.15 Storage and Handling ....................................................................... 31
6.16 Disposal............................................................................................ 31
7.0 REPLACEMENT OF YOUR OPTIMIZER SMART MINI IPG ..................... 32
8.0 FREQUENTLY ASKED QUESTIONS........................................................ 32
APPENDIX I ......................................................................................................... 34
Statement of FCC Compliance ..................... Error! Bookmark not defined.
FCC Compliance of the Vesta ChargerError! Bookmark not defined.
FCC Compliance of the OPTIMIZER Smart Mini IPG ................ Error!
Bookmark not defined.
Electromagnetic Immunity .......................................................................... 34
Electromagnetic Immunity of the Vesta Charger .............................. 34
Electromagnetic Immunity of the OPTIMIZER Smart Mini IPG ......... 37
Electromagnetic Emissions ........................................................................ 42
Electromagnetic Emissions from the Vesta Charger ........................ 42
Electromagnetic Emissions from the OPTIMIZER Smart Mini IPG ... 47
Wireless Technology .................................................................................. 49
Quality of Service (QoS) for Communications between the Vesta
Charger and the OPTIMIZER Smart Mini IPG ........................ 51
Troubleshooting Wireless Connection between OPTIMIZER Smart
Mini IPG and Vesta Charger ................................................... 53
IMPORTANT MEDICAL NOTICE
Any serious incident should be reported to the manufacturer Impulse
Dynamics by emailing QualityComplaints@impulse-dynamics.com.
According to MDR 2017/745, a ‘serious incident’ means any incident that
directly or indirectly led, might have led, or might lead to any of the
following:
a) The death of a patient, user, or other person,
b) The temporary or permanent serious deterioration of a patient’s,
users, or other person’s state of health. A serious deterioration in
the health of the subject, that resulted in any of the following:
i. Life-threatening illness or injury,
ii. Permanent impairment of a body structure or a body
function,
iii. Hospitalization or prolongation of patient hospitalization,
iv. Medical or surgical intervention to prevent life-threatening
illness or injury or permanent impairment to a body
structure or body function,
v. Chronic disease,
c) A serious public health threat. A public health threat is an event
which could result in imminent risk of death, serious deterioration
in a person’s state of health, or serious illness, that may require
prompt remedial action, and that may cause significant morbidity
or mortality in humans, or that is unusual or unexpected for the
given place and time.
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1
1.0 INTRODUCTION
Congratulations on receiving your OPTIMIZER Smart Mini System. The
purpose of this manual is to provide you with information about the
OPTIMIZER Smart Mini system, what to expect after your implant
procedure, introduce you to the components of the system, and provide
you with instructions on how to use the Vesta Charger.
Heart failure is a clinical condition that annually affects an estimated 10
million people worldwide. A recent study in the United States found the
incidence of heart failure in men was 378 per 100,000, while in women it
was 289 per 100,0001.
Heart failure is the term doctors use to describe the signs and symptoms
associated with the inability of the heart muscle to pump enough blood to
meet the needs of the body.
The symptoms of heart failure include:
difficulty breathing
swelling (edema) of the legs and/or arms
fatigue
poor exercise tolerance
mental confusion
Many medications of differing actions are currently available for the
treatment of heart failure. Despite this growing list, some patients fail to
respond to these medications or cannot tolerate their side effects,
resulting in the progressive worsening of their heart failure.
2.0 THE OPTIMIZER SMART MINI SYSTEM
The OPTIMIZER Smart Mini system is comprised of the following
components:
OPTIMIZER Smart Mini Implantable Pulse Generator (IPG)
Vesta Charger
1 Trends in Heart Failure Incidence and Survival in a Community-Based
Population, Véronique L. Roger MD, et al; JAMA. July 21, 2004; 292:344-350.
2
2.1 OPTIMIZER Smart Mini Implantable Pulse
Generator
The OPTIMIZER Smart Mini Implantable Pulse Generator (IPG) is
a medical device intended for the treatment of moderate to severe
heart failure. It is typically implanted under the skin in the upper
left or right chest.
Connected to the OPTIMIZER Smart Mini IPG are two (or
optionally three) cardiac leads that your doctor will insert through
a large vein and into the heart during the implantation process.
These leads have electrodes that allow the OPTIMIZER Smart
Mini IPG to monitor the electrical activity of your heart and deliver
special Cardiac Contractility Modulation (CCM) therapy pulses to
the heart at a specific time during each heartbeat.
The primary effect of this CCM therapy is an increase in the
efficiency and strength of each cardiac contraction, with the
intended result being that more blood is pumped out by the heart
with every heartbeat.
The OPTIMIZER Smart Mini IPG is powered by a rechargeable
battery to extend its service life. A charger specifically designed to
recharge the battery of the OPTIMIZER Smart Mini IPG will be
provided to you after your implant surgery.
The expected life of the OPTIMIZER Smart Mini IPG is limited by
the expected service life of its rechargeable battery.
With weekly charging of your OPTIMIZER Smart Mini IPG, the
rechargeable battery inside the OPTIMIZER Smart Mini IPG
should provide you with at least 20 years of service.
Your OPTIMIZER Smart Mini IPG will need to be replaced when
its battery, after being fully recharged, can no longer maintain
enough charge to deliver CCM therapy for an entire week without
becoming severely depleted.
When being evaluated for elective replacement, you will be
instructed to fully charge your OPTIMIZER Smart Mini IPG 7 days
before your scheduled routine checkup. During your checkup,
your doctor may evaluate the charge capacity of the battery in
your OPTIMIZER Smart Mini IPG.
3
Figure 1: OPTIMIZER Smart Mini IPG
2.2 Vesta Charger
The Vesta Charger is powered by a rechargeable battery and is
specifically designed for use with the OPTIMIZER Smart Mini IPG.
After your implant procedure, you will be provided with a Vesta
Charger and receive instructions on its usage. Please proceed to
Section 6.0 for more details about your Vesta Charger.
Figure 2: Vesta Charger
4
3.0 POTENTIAL COMPLICATIONS
3.1 Complications Associated with Implantation
As with any surgical procedure, the implantation of the
OPTIMIZER Smart Mini IPG involves some degree of risk. This
section is intended to provide you with an explanation of the
various potential complications associated with having a device
implanted. These potential complications are not unique to the
OPTIMIZER Smart Mini IPG, as they may also occur during the
implantation of other implantable cardiac devices (e.g., cardiac
pacemakers or defibrillators).
The risks associated with the implantation are listed in Table 1
and are grouped based on their prevalence.
Table 1: Risks Associated with Implantation
Common (greater than or equal to 5%)
Post-procedural pain, bruising, and discomfort at insertion site
Bleeding
Infection at site of insertion
Pocket hematoma
Migration of leads
Migration of
implanted IPG
Uncommon (between 1
-
5%)
Chest trauma (such as a collapsed lung or bleeding into the
chest)
Generator complication
Cardiac perforation (puncture of the heart caused by the
leads)
Endocarditis (infection of the heart valves)
Arrhythmia (irregular heartbeat, including heartbeats that are
too slow or too fast)
Tricuspid valve damage (the valve between the right upper
and lower chambers of the heart that prevents blood from
flowing back into the upper chamber), possibly leading to
tricuspid valve regurgitation or leakage
Vessel trauma (perforation, dissection, or rupture)
Thrombosis (formation of blood clots in the veins)
Damage to the specific type of heart tissue responsible for
triggering heartbeats (i.e., the cardiac conduction system)
Allergic reaction
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